GENERIC NAME OF THE MEDICINAL PRODUCT:
QUALITATIVE AND QUANTITATIVE COMPOSITION:
Composition:
Each vial contains:
Clarithromycin IP…………………500mg
Lactobionic Acid BP………………q.s.
1 Ampoule contains:
Sterile Water for Injection IP…………10ml
THERAPEUTIC INDICATIONS:
DIRECTION OF USE:
CAUTION AND SCHEDULE:
The reconstituted solution should be used immediately or used within 24 hours when stored between 2°C to 8°C.
Warning: Use only Sterile Water for Injection IP for initial reconstitution. Sodium Chloride or any other diluents should not be used for initial reconstitution. If precipitates & solution will become hazy.
SCHEDULE: SCHEDULE H PRESCRIPTION DRUG-CAUTION: Not to be sold by retail without the prescription of a Registered Medical Practitioner.
STORAGE & DOSAGE:
FLIP-OFF SEAL IS PROVIDED FOR TAMPER EVIDENCE
KEEP OUT OF REACH OF CHILDREN
Refer pack insert for further information.
DOSAGE: As directed by Physician.
Clarithromycin for Injection BP 500mg Technical Specification:
Product Name: | Clarithromycin for Injection BP |
Brand Name: | Bruxian |
Strength: | 500mg |
Dosage Form: | Lyophilized Dry Powder for Solution for Injection/Infusion |
Packing: | 1 Vial + WFI in a Tray |
Route of Administration: | For I.V. use only |
Pack Insert/Leaflet: | PIL (Patient Information Leaflet) |
Documents: | COA, MOA, Product Permission, Stability Studies, GMP |
Therapeutic use: | Antibiotic (Macrolide) |
Indication: | Clarithromycin is used to treat certain bacterial infections, such as pneumonia (a lung infection), bronchitis (infection of the tubes leading to the lungs), and infections of the ears, sinuses, skin, and throat. |
Storage: | Store below 25°C. Protect from light. |
GENERIC NAME OF MEDICINAL PRODUCT:
- Clarithromycin for Injection BP 500mg
QUALITATIVE AND QUANTITATIVE COMPOSITION:
- Clarithromycin for Injection BP 500mg
Composition:
Each vial contains:
Clarithromycin IP…………………500mg
Lactobionic Acid BP………………q.s.
1 Ampoule contains:
Sterile Water for Injection IP…………10ml
THERAPEUTIC INDICATION:
Clarithromycin is used to treat certain bacterial infections, such as pneumonia (a lung infection), bronchitis (infection of the tubes leading to the lungs), and infections of the ears, sinuses, skin, and throat.
DIRECTION OF USE:
Shake vigorously with 10ml of sterile water for injection IP for 2-3 minutes to get clear solution before administration.
CAUTION AND SCHEDULE:
CAUTION: Not to be used if the reconstituted solution contains any visible particles.
The reconstituted solution should be used immediately or used within 24 hours when stored between 2°C to 8°C.
Warning: Use only Sterile Water for Injection IP for initial reconstitution. Sodium Chloride or any other diluents should not be used for initial reconstitution. If precipitates & solution will become hazy.
SCHEDULE: SCHEDULE H PRESCRIPTION DRUG-CAUTION: Not to be sold by retail without the prescription of a Registered Medical Practitioner.
STORAGE AND DOSAGE:
STORAGE: Store below 25°C. Protect from light.
FLIP-OFF SEAL IS PROVIDED FOR TAMPER EVIDENCE
KEEP OUT OF REACH OF CHILDREN
Refer pack insert for further information.
DOSAGE: As directed by Physician.